Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:

Best tolerated dose of 2 different doses of orally administered pioglitazone [ Time Frame: From first dose to 1 day after last dose of drug ]

Secondary Outcome Measures:

Toxicities associated with both dose levels [ Time Frame: From first dose to 1 day after last dose of drug ]

To evaluate the effect of pioglitazone on glycemic levels and hemoglobin A1c values when pioglitazone is used as a cytoprotective agent concurrent with radiotherapy in normoglycemic patients. [ Time Frame: From first dose to 1 day after last dose of drug ]

Patients must have agreed to be treated with fractionated, external beam radiation treatment (EBRT) with either curative or palliative intent (the length of the radiation course must at least be ten fractions)

Patients must have agreed to have CT and MR imaging for purposes of radiation treatment planning, radiation treatment monitoring, and/or radiation treatment evaluation

Patients must have measurable disease and/or relevant anatomic features using Magnetic Resonance Imaging

Prior therapies (cytotoxic, surgery, and radiation) are acceptable

Use of steroids is acceptable when indicated

Patients must be able to understand and willingly give informed written consent to participate

Women of childbearing potential must not be pregnant or nursing and must use medically appropriate contraception if sexually active

Patients must have a life expectancy of greater than 3 months

Patients must be willing to comply with an oral treatment regimen and be able to swallow oral study tablets

Exclusion Criteria:

History of allergic reactions to pioglitazone or any other member of the thiazolidinedione family

Current diagnosis of diabetes as defined by fasting blood sugar > 125, treatment with anti-diabetic medications, or history of diabetes

Patients who take insulin

Patients who have NYHA class III or IV heart failure

Patients who have elevated transaminases (AST or ALT > 2.5 times normal limit)

Patients who are significantly anemic (hematocrit < 33% in men, or < 30% in women)

Patients who have symptomatic edema (>= grade 2)

Patients who are on medications that have been shown to have a drug interaction with pioglitazone: atorvastatin (doses > 80 mg/day), systemic anti-fungals, medications with significant CYP 3A4 inhibiting properties

Pregnant women are excluded from this study if their pregnancy precludes radiation treatment because ionizing radiation used in radiation treatment is an agent with known potential for teratogenic or abortifacient effects

Patients with psychiatric or social illnesses that may impair compliance with the trial requirements

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151670